Denosumab (Xgeva™, Prolia™)

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About Denosumab

Cancer cells from some tumors (most commonly breast, prostate and lung cancers) can spread to the bone, which is called bone metastasis. These cancer cells cause breakdown or wearing away of normal bone. In turn, affected bones become more fragile; they may be painful and can even break due to the damage from the cancer cells. Denosumab is a type of monoclonal antibody, which is a medicine designed to target a specific protein or cell – in this case, the target is a protein called RANKL, which is necessary for bone breakdown. By targeting RANKL, denosumab inhibits bone breakdown.

How to Take Denosumab

Denosumab is given every 4 weeks by subcutaneous injection (given under the skin, similar to insulin). In addition, your healthcare provider will want you to take calcium and vitamin D supplements to help with your bone health and prevent your blood calcium levels from getting too low. Talk with your team about what doses are right for you. You should drink plenty of fluids while taking this medication. Try to drink 8-10 glasses of non-alcoholic, non-caffeinated liquids a day.

Possible Side Effects of Denosumab

There are a number of things you can do to manage the side effects of Denosumab. Talk to your doctor or nurse about these recommendations. They can help you decide what will work best for you. These are some of the most common side effects:

Nausea and/or Vomiting

Take anti-nausea medications as prescribed. If you continue to have nausea or vomiting, notify your doctor or nurse so they can help you manage this side effect. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try antacids, (e.g. milk of magnesia, calcium tablets such as Tums), saltines, or ginger ale to lessen symptoms. Read the Nausea & Vomiting Tip Sheet for more suggestions.

Call your doctor or nurse if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Fatigue

While on cancer treatment you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team and see OncoLink's section on fatigue for helpful tips on dealing with this side effect.

Low Blood Calcium

Denosumab can cause your blood calcium levels to drop below normal. You will take calcium and vitamin D supplements to prevent the level from getting too low. Signs that calcium levels are low include: numbness or tingling sensation around the lips, muscle stiffness, twitching, spasms or cramps. Be sure to notify your oncology team if these symptoms occur.

Osteonecrosis of the Jaw

Osteonecrosis of the jaw (ONJ) is a rare side effect, however, it is important that you know about it and take steps to protect your dental health. The maxilla (upper jaw bone) and mandible (lower jaw bone) are normally covered by gum tissue. In the case of ONJ, this tissue is gone and the bone is exposed. Typical symptoms associated with ONJ are: pain, swelling or infection of the gums, loosening of the teeth, exposed bone (often at the site of a previous tooth extraction). Some patients may report numbness or tingling in the jaw or a "heavy" feeling jaw. ONJ may have no symptoms for weeks or months and may only be recognized by the presence of exposed bone. ONJ most often occurs soon after a dental procedure, but this is not required for ONJ to occur.

Prior to starting therapy with denosumab, you should have a complete dental exam, cleaning, and removal of any teeth in poor health.

Dentures should be checked for proper fit.

Brush your teeth after meals and at bedtime with a soft brush. Floss gently once a day. If your gums bleed, talk with your healthcare team to see if you can continue to floss.

Check your teeth and gums in a mirror daily for any sores, swelling, loose teeth, pain or numbness, or other changes and report these to your dentist or oncology team immediately.

Avoid any dental surgery or invasive dental procedures while on bisphosphonate therapy.

Mar 31, 2015 - In patients with bone metastases from prostate, breast or other cancers, who have elevated urinary N-telopeptide levels despite ongoing intravenous bisphosphonate therapy, treatment with denosumab may be more effective at normalizing levels and reducing skeletal-related events than continuation of bisphosphonate therapy, according to a report published in the Mar. 1 issue of the Journal of Clinical Oncology.